Quality Control Assurance
Resume:
DHAVALKUMAR B. PATEL
Ewing, NJ 08168
Cell – 201-***-****
******.*********@*****.***
OBJECTIVE: To utilize my knowledge and skills towards a challenging career in a growth oriented & leading edge organization that recognizes and values individual contribution & will provide opportunity for continuing growth and advancement.
EDUCATION: Stevens Institute of Technology, Hoboken, New Jersey
Master of Science in Pharmaceutical Manufacturing Engineering GPA: 3.46 December 2010
Major Subjects:
Introduction of Pharmaceutical Manufacturing, Validation and Regulatory Affairs in Pharmaceutical Manufacturing, Introduction to Project Mgmt, Good Manufacturing Practices (GMP) in Pharmaceutical Facility Design, Pharmaceutical Finishing and Packaging, Quality in Pharmaceutical Manufacturing, Engineering Economics and Cost Analysis, Regulation and Compliance in Pharmaceutical Industry.
S.K. Patel College of Pharmaceutical Research and Education,
Ganapat University, Gujarat, India May 2008
Bachelor of Pharmacy
First Class
PROJECTS: These are the projects on I have worked in my master study.
• Internal audit
• NDA application
• Quality award
• Green approach in pharmaceutical industry
• Sterile facility design
• FDA
SKILLS: Lab Skills: UV-Vis Spectrophotometer, Colorimeter, tablet Punching machine, Dissolution Apparatus, Disintegrator, Titration and Preparation of Chemical Solutions. Fluid bed dryer
Software:
• MS office
• MS Project
• Minitab
• SAS Programming (Base, Macros, Access, Graph)
• Knowledge of the drug development and analyzing and reporting of clinical trial data
• Working Knowledge of extracting data from clinical dataset and flat SAS files
• Experience in developing analysis plans including specs for tables, graphs, listing and validation.
• Experience in clinical data management and data analysis
• Familiar with 21 CFR 11 compliant statistical system
• Performed Quality checks on existing table, listing and figures.
• Involved in creating safety and efficacy tables.
• Experience in developing and analysis of SOP for new processes.
• Experiences in statistical process control of content uniformity study.
• Knowledge of regressive analysis, factor analysis and cluster analysis.
• Knowledge of DOE and Time series and forecasting.
TRAINING: Excel Health Care Pvt Ltd, Mehsana, Gujarat, India
Trainee: May – July 2008
• Performed mixing, blending, granulation in tablet manufacturing department.
• Trained in sampling and analytical testing of raw and finished materials using UV Spectrophotometer and Flourimeter
• Participate in SOP review and new SOP formation
EXPERIENCE: Excel Health Care Pvt Ltd, Mehsana, Gujarat, India
Position: Production Supervisor and Data analyst
• Maintained record of Production activities. (Granulators, tablet compression, raw material transfer).
• Generated Graphs and charts using SAS/GRAPH.
• Conducted DATA analysis for tables, listings and graphs for accuracy and consistency.
• Analyzed validated data for product compatibility, efficacy and safety.
• Participated in internal audit and also in Qualification team, SOP reviewer team.
• Converted raw data from MS EXEL, CSV and MS ACCESS to SAS data sheet.
Mann Pharmaceuticals, Mehsana, Gujarat, India
Position: Quality control and Data analyst
• Involved in Phase 1 and Phase 2 data analysis.
• Generated listings and tables for the NDA submission.
• Extracted data using the SAS/access and analyzed the data to create a report.
• Developed safety and efficacy tables for FDA submission.
• Prepared CAPA action for some processes and also performed root cause analysis.
• Conducted the regression, correlation studies and analysis of variance.
Sanofi Pasteur Pharmaceuticals, Swiftwater, Pennsylvania
Position: Manufacturing Technician
• Operated filling equipment
• CIP, SIP, Environment Monitoring
• Generated the report of EM and submitted them with conclusion.
• Participated in Quality control and safety meetings
KvK Tech. incorporation, New Town, Pennsylvania
Position: Production Technician
• Operator of Blending, Compression
• Inventory Control and Packaging
• Reviewed SOPs and participating in formation of new method writing of SOP
• Trainee of the Quality Assurance for Final Blend and In process Compression
HOBBIES: Music, Traveling, Movie
REFERENCES: Available Upon Request
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